Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062931
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/29/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/22/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-18 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062931s018lbl.pdf
02/01/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/2001 SUPPL-8 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/09/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/04/2000 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/15/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/18/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/25/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/10/1995 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/09/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2011 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/062931s018lbl.pdf

VANCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205780 AUROBINDO PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202275 EMCURE PHARMS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062663 FRESENIUS KABI USA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205694 GLAND PHARMA LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 212332 HAINAN POLY PHARM
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062911 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 062931 HOSPIRA
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065401 MUSTAFA NEVZAT ILAC
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065397 MYLAN LABS LTD
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090250 SANDOZ
VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204107 XELLIA PHARMS APS

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